Job Description

Specialist, QA Engineering
Job Number: 21-09828
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Specialist, QA Engineering for our client in Devens, MA
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • This individual will be responsible for providing Quality oversight to Commissioning, Qualification and Validation (CQV) activities for the startup of the Devens Cell Therapy Facility.
 
Responsibilities:
  • Provides document review and approval for facility, equipment, and utility commissioning and qualification, process validation, computer system and analytical validation documentation from both technical and compliance perspectives
  • Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence
  • Reviews and approves protocol discrepancies associated with the qualification and startup of the Devens Cell Therapy Facility and participates in resulting investigations and correction / corrective action planning
  • Provides quality oversight for calibration and maintenance activities
  • Identifies unresolved issues/decisions related to validation documents and coordinates resolution with other departments
  • Demonstrates appropriate examples for compliance behaviors and attitudes
  • Meets and exceeds all safety expectations and adheres to all Client behaviors
  • Provides quality oversight on Technology Transfer initiatives
  • Verifies compliance with applicable Client Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications
 
Qualifications:
  • Knowledge of science generally attained through studies resulting in a Bachelor's Degree in a scientific or engineering discipline or its equivalent
  • A minimum of 8 years experience in an environment governed by cGMPs, including at least 5 years of validation-related experience, (e.g., equipment qualification, computer system validation, analytical equipment / method validation, or process validation)
  • Knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes
  • Firm understanding of quality systems
  • Proficiency in the use of computers and software applications including electronic validation documentation systems, such as ValGenesis
  • Demonstrated interpersonal, communication, and motivation skills
  • Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking
  • Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva Vault is desirable
  • Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable
  • Effective written and verbal communication skills
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
 
Equal Opportunity Employer:
Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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